Lilly's oral GLP-1, orforglipron, demonstrated statistically significant efficacy results and a safety profile consistent with injectable GLP-1 medicines in successful Phase 3 trial

Core Insights - Orforglipron is the first oral small molecule GLP-1 receptor agonist to successfully complete a Phase 3 trial, demonstrating significant efficacy in lowering A1C levels and reducing weight in adults with type 2 diabetes [1][5][6] - The investigational drug showed an average A1C reduction of 1.3% to 1.6% from a baseline of 8.0% and an average weight loss of 16.0 lbs (7.9%) at the highest dose [1][2][3] - The safety profile of orforglipron was consistent with existing injectable GLP-1 therapies, with gastrointestinal-related adverse events being the most common [4][5] Efficacy Results - In the ACHIEVE-1 trial, orforglipron met the primary endpoint of superior A1C reduction compared to placebo, with reductions of 1.3% (3 mg), 1.6% (12 mg), and 1.5% (36 mg) versus 0.1% for placebo [2][3] - Over 65% of participants on the highest dose achieved an A1C of 6.5% or lower, which is below the American Diabetes Association's threshold for diabetes [1][2] - Weight reduction results showed a decrease of 4.7% (3 mg), 6.1% (12 mg), and 7.9% (36 mg) from a baseline weight of 90.2 kg (198.9 lbs), compared to 1.6% for placebo [2][3] Safety Profile - The overall safety profile of orforglipron was consistent with the GLP-1 class, with common adverse events including diarrhea (19%-26%), nausea (13%-18%), and dyspepsia (10%-20%) [4][5] - Treatment discontinuation rates due to adverse events were 6% (3 mg), 4% (12 mg), and 8% (36 mg) for orforglipron, compared to 1% for placebo [4] Future Developments - The results from the ACHIEVE-1 trial will be presented at the ADA's 85th Scientific Sessions and published in a peer-reviewed journal, with additional data expected later this year [5][8] - Lilly plans to submit orforglipron for weight management to global regulatory agencies by the end of this year, with submissions for type 2 diabetes anticipated in 2026 [5][8] Company Background - Eli Lilly and Company is focused on developing innovative treatments for chronic diseases, including type 2 diabetes, and has a long history of pioneering medical discoveries [9]